June 11th, 2014, 11.00-12.00 CET (10.00-11.00 UK time)
The European Medicines Agency believes that incorporating the knowledge, views and preferences of patients throughout the lifecycle of medicines adds value to the scientific assessment. In addition, patient groups have been the key drivers of implementing accelerated approval pathways partnership with the FDA in the United States.
Because the views of patients on the benefit and risk of a medicine can differ from those of other stakeholders, how should benefit risk preferences be weighed by patients and practitioners when evaluating new accelerated pathways, such as the EMA’s pilot project in MAPPs (Medicine Adaptive Pathways to Patients)?
This webinar served to answer several key questions:
- How do we balance the need for timely access new medicines and benefit risk?
- Who ultimately should choose what level of uncertainty is acceptable?
- What are good examples of tools and methods for making informed benefit risk decisions with increased uncertainty?